PRIMODENT ACRYLIC TEETH— 510(k) K926070

Substantially Equivalent

I.T.C. Ent.

FDA 510(k) clearance K926070 for PRIMODENT ACRYLIC TEETH, Substantially Equivalent on 1994-02-17. Applicant: I.T.C. Ent.. Device class: 2.

Clearance details

Applicant: I.T.C. Ent.
Product code: Code ELM
Device class: Class 2
Regulation: 21 CFR 872.3590
Advisory panel: Dental
Date received: 1992-12-01
Decision date: 1994-02-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Marietta, GA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.